Tests sonrotoclax with zanubrutinib for returning mantle cell lymphoma
Compares sonrotoclax plus zanubrutinib with placebo plus zanubrutinib in adults with mantle cell lymphoma.
Plain-language title generated from the registry record
Registry title: A Study to Investigate the Efficacy and Safety of Sonrotoclax Plus Zanubrutinib Compared With Placebo Plus Zanubrutinib in Adults With Relapsed/Refractory Mantle Cell Lymphoma (CELESTIAL-RRMCL)
Key facts
- Where
- Bunkyoku, Chiba, Hiroshima, Kagoshima, KobeShi, Koshigaya, Kurashikishi, Matsuyama, Nagoya, Ōgaki, Okayama, Osaka, Osakashi, Sapporo, Sendai, Toyohashishi, and Yokohama, JapanSee the 18 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mantle cell lymphoma that came back or did not respond after earlier treatment. It compares sonrotoclax plus zanubrutinib with placebo plus zanubrutinib.
- Age
- 18 years or older
- Sex
- All sexes can join.
- Disease stage
- Mantle cell lymphoma that came back or did not respond after the last treatment. At least 1 lesion that can be measured (a node larger than 1.5 cm (0.6 in) or another lesion larger than 1 cm (0.4 in)). ECOG performance status of 0 to 2.
- Earlier treatment
- Must have had 1 to 5 earlier lines of treatment, including an anti-CD20 antibody-based treatment. Cannot have had earlier BCL2 inhibitor or BTK degrader therapy. Earlier BTK inhibitor therapy is not allowed, unless the person could not tolerate a BTK inhibitor other than zanubrutinib.
Main reasons for not taking part
- Earlier BCL2 inhibitor or BTK degrader therapy
- Earlier BTK inhibitor therapy, except intolerance to one other than zanubrutinib
- Autologous stem cell transplant or CAR T-cell therapy within 3 months before the first dose
- Allogeneic stem cell transplant within 6 months before the first dose
- Known lymphoma in the central nervous system
Read by machine on 9 November 2026.
Where in Japan
- Institute of Science Tokyo HospitalBunkyoku, JapanContact: Study DirectorTaking people
- Chiba Cancer CenterChiba, JapanContact: Study DirectorTaking people
- Hiroshima Red Cross Hospital and Atomic Bomb Survivors HospitalHiroshima, JapanContact: Study DirectorTaking people
- Kagoshima University HospitalKagoshima, JapanContact: Study DirectorTaking people
- Kobe City Medical Center General HospitalKobeShi, JapanContact: Study DirectorTaking people
- Dokkyo Medical University Saitama Medical CenterKoshigaya, JapanContact: Study DirectorTaking people
- Kurashiki Central HospitalKurashikishi, JapanContact: Study DirectorTaking people
- Matsuyama Red Cross HospitalMatsuyama, JapanContact: Study DirectorTaking people
- Aichi Cancer Center Hospital Clinical OncologyNagoya, JapanContact: Study DirectorTaking people
- Ogaki Municipal HospitalŌgaki, JapanContact: Study DirectorTaking people
- National Hospital Organization Okayama Medical CenterOkayama, JapanContact: Study DirectorTaking people
- Osaka Metropolitan University HospitalOsaka, JapanContact: Study DirectorTaking people
- Osaka Red Cross HospitalOsakashi, JapanContact: Study DirectorTaking people
- Hokkaido University HospitalSapporo, JapanContact: Study DirectorTaking people
- Tohoku University HospitalSendai, JapanContact: Study DirectorTaking people
- Toyohashi Municipal HospitalToyohashishi, JapanContact: Study DirectorTaking people
- Kanagawa Cancer CenterYokohama, JapanContact: Study DirectorTaking people
- Yokohama Municipal Citizens HospitalYokohama, JapanContact: Study DirectorTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- BeOne Medicines
- Trial code
- NCT06742996EU 2024-515593-27-00
- Record updated
- 29 October 2026
- Original description
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.Read full original descriptionShow less
A Phase 3 Randomized Double-Blind Multicenter Study of Sonrotoclax Plus Zanubrutinib Versus Placebo Plus Zanubrutinib in Patients With Relapsed/Refractory Mantle Cell Lymphoma
The goal of this study is to compare how well sonrotoclax plus zanubrutinib works versus zanubrutinib plus placebo in treating adults with relapsed/refractory (R/R) mantle cell lymphoma (MCL). This study will also look at the safety of sonrotoclax plus zanubrutinib versus zanubrutinib plus placebo.
Inclusion: Histologically locally confirmed diagnosis of MCL based on the World Health Organization 2022 classification of Haematolymphoid Tumors (WHO-HAEM5), or based on International Consensus Classification (ICC); Ability to provide archival or fresh tumor tissue for retrospective central confirmation of MCL diagnosis; Received 1 to 5 prior lines of systemic therapy including an anti-CD20 monoclonal antibody (mAb)-based immunotherapy or chemoimmunotherapy and requiring treatment in the opinion of the investigator; Relapsed or refractory disease after the last line of therapy; Measurable disease defined as ≥ 1 nodal lesion that is > 1.5 cm in longest diameter, or ≥ 1 extranodal lesion that is > 1 cm in longest diameter; Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2; Adequate organ function.
Exclusion: Prior therapy with B-cell lymphoma-2 inhibitor (BCL2i); Prior therapy with BTK degraders; Prior therapy with covalent or non-covalent Bruton tyrosine kinase inhibitor (BTKi) unless the participant was intolerant of non-zanubrutinib covalent or non-covalent BTKi. Participants with refractory disease to BTKi therapy or relapse attributed to failure of BTKi therapy are ineligible; Prior autologous stem cell transplantation or chimeric antigen receptor T-cell therapy within 3 months before first dose of study drug; Prior allogeneic stem cell transplant within 6 months of the first dose of the study drug; History of stroke or intracranial hemorrhage within 6 months before first dose of study drug; Note: Other protocol defined Inclusion/Exclusion criteria may apply; Clinically significant cardiovascular disease; Known central nervous system involvement by lymphoma.